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At Houston Methodist, the Manager Clinical Research Coverage Analysis position is responsible for the Coverage Analysis Program at Houston Methodist Research Institute (HMRI). The Manager of the Clinical Research Coverage Analysis position is responsible for the day-to-day operations of the department to include reviewing clinical research protocols, informed consent forms, clinical trial agreements, and other relevant study-related documents in order to facilitate the coverage analysis process. The position will manage and oversee the coverage analysis process for clinical research studies that meet the criteria for qualifying clinical trials as defined by the Medicare Clinical Trial Policy (NCD 310.1) and will also be the subject matter expert and work with the research billing team and management on Medicare/Medicaid Benefit Policies, third-party Medical Benefit Policies, relevant National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs), Code of Federal Regulations (CFRs), state laws, professional practice guidelines, and claims denial report. The position will provide training on the coverage analysis process, perform operational process review and implementation, and ensure Quality Assurance (QA) with Standard Operating Procedures (SOPS).

The Manager Clinical Research Coverage Analysis responsibilities include managing the daily activities of the work unit/department staff, ensuring quality, productivity, functional excellence, and efficiency while assisting management in accomplishing strategic and operational objectives. In addition, this position guides staff and is responsible for staffing, budget compliance, coaching and counseling employees on work-related performance, and assisting in the development and implementation of policies and procedures to ensure a safe and effective work environment. This position implements training, monitoring, and operations initiatives that secure compliance with ethical and legal business practices and accreditation, regulatory, and government regulations.

PEOPLE ESSENTIAL FUNCTIONS

• Manages, develops, and implements strategic and operational/high-level projects and processes either through independent/highly autonomous work or through the facilitation of work teams to enable the effective and efficient completion of objectives.

• Oversees management of and ensures development for staff to meet overall objectives in terms of quality, service, and cost-effectiveness. Provides timely guidance and feedback to help others strengthen specific knowledge or skill areas needed to accomplish a task or solve a problem. Directs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees. Meets or exceeds threshold goal for department turnover and system metrics on employee engagement indicators.

• Provides leadership and communication to maintain a competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coaching/corrective counseling, and providing recognition/commendations to achieve desired outcomes.

• Identifies opportunities and takes action to build strategic relationships between one's area and other areas, teams, departments, and units to achieve business goals. Drives the promotion of teamwork within and between departments; participates and/or leads and facilitates department process improvements as needed.

• Collaborates with Houston Methodist (HM) leaders to standardize the clinical research coverage analysis process and management across HM organizations.

• Coordinates with IT to ensure the implementation and optimization of processes that support the clinical research billing functionality in the Epic and OnCore environments as it pertains to the Coverage analysis process which includes oversight of a team of individuals to ensure processes are in place to support the technology and the development of a quality assurance team to ensure the synchronization of Epic and OnCore.

SERVICE ESSENTIAL FUNCTIONS

• Oversees department operations, designated projects, schedules, and activities as needed to ensure that goals or objectives are accomplished within the prescribed time frame. Sets priorities and functional standards, giving direction to staff as necessary to ensure the best possible delivery of service and high customer and patient satisfaction.

• Drives department service standards and activities to impact department and system score for patient/customer-based satisfaction, through role modeling and fostering accountability. Serves and actively participates on various entity committees as a voice for the department.

• Provides oversight, leadership, and support for the development of the clinical research coverage analysis office which includes the accuracy of the study calendar and coverage analysis for Qualified Clinical Trials (QCT)submitted for the review process in the Administrative Review and Forms (ARAF) in the Houston Methodist IRB system. This position may also assist with negotiation of the contract budget with the departments as requested, quality assurance process between clinical trials management system and electronic health record, review of charges related to clinical research activities, and monitoring of the actively enrolling clinical trials.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Ensures a safe and effective working environment; monitors and revises the department safety plan, and any specific accreditation/regulatory required safety guidelines as needed. Responsible for staff maintenance of credentials and competencies per accrediting or licensing agency, and department guidelines as applicable.

• Employs a proactive approach to the optimization of safe outcomes and information systems by monitoring and improving the department workflow and enhancing operations, using peer-to-peer accountability, and identifying solutions via collaboration. Implements process improvements utilizing tools such as lean principles. Role models situational awareness, using teachable moments to improve safety.

• Monitors self and employee compliance with policies, procedures and System HR Standards of Practice and performs associated actions upon non-compliance (i.e. FPR requirements, disaster plan, inservices, immunizations, wage and hour, standard hours, timely termination submission, timely timecard approval, etc).

FINANCE ESSENTIAL FUNCTIONS

• Develops and manages department operational and capital budgets, approvals, and ongoing maintenance of the department(s), ensuring operation cost-effectiveness. Proactively identifies and plans for capital needs related to current equipment and future department projects.

• Ensures staffing plans and schedules meet department needs that reflect an understanding of the importance of cost-effectiveness.

• Creates department strategies to achieve financial targets and staffing needs, through optimizing productivity, supply/resource efficiency, minimizing incidental overtime and overtime percentage, and other areas according to department specifications.

• Coordinates with various areas across HMRI to ensure the establishment of a standard close-out process for clinical research studies which includes the timely and accurate review of budget categories to determine allowable and non-allowable expenses based on funding source guidelines.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

• Identifies and implements innovative solutions for practice or workflow changes to improve department, entity, or system operations by leading unit projects and other department or system-directed activities. Proactively leads task forces and committees. May represent HM at assigned community or professional organization meetings.

• Drives change initiatives, maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusts effectively to work within new work structures, processes, requirements, or cultures. Partners effectively with stakeholders as appropriate.

• Coordinates with Information Technology (IT), Central Offices, and others to implement and optimize technology solutions that support clinical research activities which include the implementation and optimization of the financial modules in OnCore, continuous process improvement initiatives, and the optimization of processes to support daily operations, as needed.

This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.

EDUCATION

• Bachelor's degree in business, finance, healthcare administration, or related healthcare field

• Master's degree preferred

WORK EXPERIENCE

• 3 years of people management or supervisory experience

• 10 years in the healthcare environment: to include clinical research operations, research coverage analysis, or research billing operations

LICENSES AND CERTIFICATIONS - REQUIRED

• N/A

KNOWLEDGE, SKILLS, AND ABILITIES

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations

• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially about activities impacting patient or employee safety or security

• Demonstrates the ability to interact with others in a way that gives them confidence in one's intentions and those of the organization

• Ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one's own behavior to accommodate tasks, situations, and individuals involved

• Demonstrates leadership qualities and critical thinking through self-direction initiative and effective interpersonal skills and oral/written communication skills

• Ability to identify and understand issues, problems, and opportunities, comparing data from different sources to conclude; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences

• Ensures own career discussions occur with appropriate management. Completes and updates My Development Plan (MDP) on an on-going basis. Conducts conversations with staff on their development and MDP

• Extensive knowledge of regulatory and accreditation agency requirements that impact the department; stays abreast of industry changes

• Demonstrates highly effective communication skills-strong written communication and platform presentation abilities

• Ability to work effectively in a fast-paced environment

• Demonstrates flexibility and adaptability in the workplace

• Capable of leading teams/facilitating groups, building consensus, and garnering the highest confidence in professionalism and work product by senior leadership

• Ability to work under pressure and balance many competing priorities; highly responsive and solution/action-oriented

• Proficiency in spreadsheet, word processing, and presentation software

• Maintains a positive and supportive attitude and demeanor

• Professional handling of exposure to confidential/sensitive information

• Ability to work efficiently under stress with time limits imposed

• Interacts effectively with a variety of professionals, administrators, and support staff

• Strong analytical and interpersonal skills

• Applies sound judgment in applying and interpreting policies, procedures, laws, rules, and regulations applying to compliance and monitoring

• Knowledge of Medicare guidelines and other federal/state guidelines that govern clinical research billing

• Knowledge of the revenue cycle and the associated billing practices

SUPPLEMENTAL REQUIREMENTS

WORK ATTIRE

• Uniform No

• Scrubs No

• Business professional Yes

• Other (department approved) No

ON-CALL*

*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.

• On Call* No

TRAVEL

Travel specifications may vary by department

• May require travel within the Houston Metropolitan area No

• May require travel outside Houston Metropolitan area No

Company Profile:

Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care.

Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs.

Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.

Houston Methodist is an Equal Opportunity Employer.

Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.